This invention relates to digestible and volume adjustable container devices and multi-medication combination systems that can be used to hold (stack) and ingest simultaneously or sequentially multiple medication products, pharmaceuticals, nutritional products and inert materials.
Through their structure, the delivery devices have the ability to organize a patient's multiple medications into a reduced number of containers. The medication delivery devices are not limited by medication content, type (capsule, tablet, soft gel) or form. The content of these medication delivery systems are easily visually recognizable by the physician or patient. Additionally, the volume adjustable containers can be size adjusted to content or swallowability by both the manufacturer and the consumer. Also, they can be easily opened by the user if so desired.
As used herein, “pill” means any mechanism or means for delivery of medication products or elements to a live body, including, but not necessarily limited to, tablets, capsules, gel caps or soft-gels.
As used herein, “medication product” includes and encompasses, but is not limited to, prescription drugs, non-prescription drugs, over-the-counter drugs, nutritional supplements and inert “filler” materials used in conjunction with any of the foregoing.
As used herein, the words “container” and “containment means” include and encompass not only the traditional medication tablet, capsule, pill, gel cap, soft-gel, suppositories, skin patches and sublingual applications, but also includes and encompasses any and all other medication delivery mechanisms and means and are not synonyms for a “capsule”.
As used herein, the words “outer container” means the container or containment means which contains multiple medication products (also referred to herein as “medication elements”) as tablets, pills, capsules, soft gels, or liquids, but which itself is not connected with or affixed to another (except in the case where the outer container is connected or fitted with another container means, such as a plug, or further container or containment device in chain, train or string fashion), and which is not itself sequentially imbedded within another container, and which said non-connected and non-affixed container or containment means can be ingested or inserted into a live body. This outer container can itself be made from medication products and is biodegradable.
As used herein, the term “volume adjustable” refers to the ability to reversibly adjust the volume or number of medication elements contained within the medication delivery device. The term “volume adjustable” also refers to the ability to reversibly adjust the overall length or size of the medication delivery device The term “reversibly” means that the volume or size can be increased, then decreased (or decreased then increased) as many times as desired without effecting the integrity of the medication delivery device.
Most medications presently ingested by patients contain significant amount of inert materials or fillers. Parts of these inert materials are often present due to the concentrated nature, and thus small volume, of the actual active ingredient in the medication. If only the active ingredient was presented to a patient, it would often be of a size which was too small for the patient to comfortably handle, resulting in either the patient dropping or losing the medication or the patient ingesting an overdose of the medication.
Many studies show that age and chronic diseases are strongly correlated to the number of prescription medication pills a person is taking. Due to a continually increasingly aging population and increased use of drug therapy, more and more people find themselves taking several (perhaps as many as 4 to 10) pills for treating or preventing illnesses every day. Research has shown that even patients for whom strict adherence to prescribed drug regimens is crucial, rates of non-compliance can still range from as much as 20% to 50% and that this rate increases with the number of pills prescribed.
Each year in the United States, the consequences of poor compliance cost an estimated $100 billion in added health care expenses, lost productivity, and other direct and indirect costs, in addition to personal suffering.
Another consequence of people having to take several pills every day is that the risks of various mistakes are increased. For example, the patient can become confused as to whether they have taken their medications or not. It is then possible that they take too much or too little of their medications; this increases the likelihood that side effects can occur.
It is sadly ironic that the more confused the patient is, the more likely it is that they have even more pills to keep track of and monitor.
According to the United States Food and Drug Administration, 1.5 million Americans were hospitalized in 1978 alone as a consequence of pharmaceutical drugs administered to “cure” them. It was found that some 30% of all hospitalized people suffered further damage from the therapy prescribed to them.
Side effects involving prescription drugs are the fifth leading cause of deaths in the USA.
One means of increasing compliance is to reduce the number of pills (and containers) taken per day, thus reducing patient resistance to swallowing large numbers of pills or the possibility of patients forgetting to take some of their medication, thus reducing the risk of medication-induced error.
Moreover, numerous studies have shown that certain combinations of different substances or medications can dramatically improve the health outcomes through additional or synergic effects. But these combinations most often require the ingestion of more pills which may again lower the compliance.
The delivery of medication products, including prescription drugs, over-the-counter drugs, nutritional supplements and inert materials, has been traditionally accomplished by the use of pills.
Typically, pills are comprised of the active ingredient compounded with inert ingredients for various purposes, including ease of handling small amounts of active ingredients. When the said mixture of active and inactive ingredients is then compressed to form a tablet, the tablet typically is then coated or covered with a polished “surface” substance functioning as both a physical/chemical barrier and as a helper for smooth swallowing.
Similarly, capsules and soft-gels are composed of an outer material or casing which is dissolved after ingestion by the patient. The interior portion of the capsule or soft-gel is filled with an active ingredient compounded with inert ingredients for various purposes, including ease of handling of small amounts of active ingredients, similar to a pill as described above.
There are several distinctions between capsules vis-à-vis soft gels or gel caps. The major difference between a capsule and a soft gel or gel cap is that a capsule is usually a pre-made two-piece hard shell assembled after the medication filling is prepared, and a soft gel or gel cap is a physically softer gelatin container and made at the same time as the filling of the content. Capsules usually contain solid materials such as powders, although they occasionally do contain liquids, whereas soft gels usually contain oils or liquid, although some soft gels do contain rather powdery substances.
The disadvantage of a typical prescription pill is that it usually contains only one primary medication even when a patient needs several, thus only addressing one type of indication, problem or physiological mode of action.
Another disadvantage of typical prescription pills is that the patient typically has to buy several different pills to cover their medical needs and that the cost of each pill is higher than if the combination was produced by the same manufacturer into one package.
The treatment of many seriously ill or chronic patients requires the use of multiple medications. Many patients find having to take numerous traditional pills burdensome and restrictive, and this causes additional responsibility and worries. Not only is the patient burdened with multiple containers for the various medications, but the patient must also track each pill to assure that they have in fact timely ingested the proper dosage of each such medication.
The need for the patient to recognize each pill is fully understood by the pharmaceutical industry. When a new and patented product enters the marketplace the manufacturer designs the physical appearance of the pill and the container box to brand the medication using unique colors and shapes, being well aware of the fact that after the patent expiration, the patient will resist switching to cheaper and unfamiliar generic versions (with new colors and shapes) as this will require an adjustment of a carefully habituated visual tracking system. In this way a lack of a standardized visual identification system that everybody can understand contributes to making chronic drug therapy more expensive than necessary.
The present invention reflects the fact that:
(1) Most people (up to 70-85%) do not experience any problems swallowing oblong tablets or capsules up to the size of approximately 20-25 mm, although this size is somewhat larger than most of the prescription pills on the market. However, it still means that a substantial number of people would prefer/need smaller sizes to reduce swallowing problems;
(2) Keeping track of one large pill is easier than keeping track of numerous small pills;
(3) Keeping track of one container is easier than keeping track of several;
(4) Many prescription drugs come in pill sizes larger than chemically necessary and the active ingredient is often so minute it needs to be sized up with fillers to become manageable for the consumer, or it needs to fit a specific shape for marketing purposes;
(5) The physician wants to be able to remove or change the dose of particular medications due to the patient response while holding other substances constant;
(6) Combining several medications can increase the therapy effect and reduce side effects;
(7) There are presently no national or international standards for sizes, shapes, colors or visual identification codes for individual pills. Instead, even the same generic component can come in a variety of appearances compared to the brand of the original manufacturer. This makes it confusing and difficult for the patient to switch from one manufacturer to another for the same medication or even for the physician to identify the content of most medication pills or to renew prescriptions in other countries while traveling. It also hinders the development of a basis for automated individualized multi medication prescription fulfillment, where the elements would need to come in some standardized forms. The proposed suggestion of mandatory bar codes on containers by FDA will not solve these problems. Additionally, it is legal to send medications in the mail, even from one country to another. It is a well known problem that this practice gives the opportunity to send illegal substances under the cover of simple capsules. A new visual identification system will lower this risk.
Combining the fact that it is physically possible to add many prescription drugs together into one container, and still maintain an overall volume which is easy to swallow for most people, opens up the possibility of solving the above mentioned compliance problems related to the number of pills and reducing the risk of taking too much or little medication.
Combining the fact that it is physically possible to present multiple medications and combinations into a reduced number of swallowable sized containers, makes it more appealing to patients and physicians to accept the use of multiple and synergistic ingredients to treat or prevent chronic diseases thus increasing drug therapy power.
Combining the fact that it is possible to create a medication container that can hold several medications and can be size adjustable or opened and separated by the patient into individual components, allowing the patient to reduce the size and swallowing problems presented when taking the medications individually, by following the instructions from the physician to remove or change part of the content, will still result in a reduced number of needed container boxes for this patient group and will help the patient to keep all the medications in one place.
An objective of the present invention is to solve the aforesaid problems, including by reducing the number of pills and containers that will contain the originally intended, prescribed or recommended medications and doses, thus increasing compliance and reducing the possibility of confusion, while maintaining the possibility to recognize each medication element and to ingest each medication element sequentially if desired
A further objective of the present invention is to create a container system that can hold a variety of substance combinations, shapes or presentations (capsules, tablets, soft gels) without chemical interaction and to present these multiple medication combinations in a reduced number of containers, thereby increasing the patient acceptance of taking multiple medications regularly.
A further objective of the present invention is also to solve the aforementioned problems by facilitating a switch, in certain instances, to relatively less expensive generic products or to combinations of generic and original drugs.
A yet further objective of the present invention is also to enable a world wide visual medication identification system and create a simple, manufacture friendly and general container device for automated patient individualized manufacturing systems/fulfillment centers/pharmacies for multiple medication prescriptions built on international standards for size, shapes, colors, symbols and configuration of pills. This visual identification system can then be translated into traditional bar codes which may be mandatory for packaging in the future.
Previous medication delivery devices known in the art include dividable capsules, dividable tablets and closed capsule systems. However, there is currently no device that allows for combining a tablet with a capsule or soft gel, or that has volume adjustable features for the patient and/or the manufacturer, or that allows for a wide variety of combinations of soft gels, tablets and capsules using as few as two standard outer container elements to efficiently host these combinations. Nor is there currently a device that combines the above mentioned features with visually identifiable different medication elements, or with a medication-containing plug system. Accordingly, improved medication delivery systems would be beneficial in the art.